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目的观察5岁以下反复呼吸道感染(RRTIs)合并喘息、经常规吸入糖皮质激素(ICS)治疗仍控制不理想的患儿,口服细菌溶解产物治疗的有效性和安全性。方法 2013年1月至2014年12月,采用前瞻、随机、单盲、安慰剂对照方法,将上海市静安区中心医院门诊40例≤5岁的RRTIs合并喘息、ICS治疗控制不佳的患儿分别纳入治疗组(20例)和对照组(20例),治疗组给予加服细菌溶解产物,对照组则给予加服安慰剂。观察两组患儿治疗前及治疗后3、6、12个月的临床疗效及不良事件发生情况,并检测相应窗口期唾液分泌型Ig A(s Ig A)水平变化。结果观察期间,治疗组患儿喘息发作次数和症状评分均呈显著下降,唾液s Ig A较对照组有明显升高,且与外周血嗜酸性粒细胞百分比下降程度呈显著负相关。用药期间未见明显不良反应。结论细菌溶解产物可以提高唾液s Ig A的水平,增强机体呼吸道黏膜局部免疫能力,减少患儿反复呼吸道感染的概率,从而有效减少喘息发作。
Objective To investigate the efficacy and safety of oral bacterial lysates in patients with recurrent respiratory tract infections (RRTIs) and wheeze under 5 years of age with conventional inhaled glucocorticoid (ICS) in patients with suboptimal control. Methods From January 2013 to December 2014, 40 patients (≤5 years) with RRTIs who were outpatient at Jing’an District Central Hospital of Shanghai City were enrolled in a prospective, randomized, single-blind and placebo-controlled study. Patients with poorly controlled ICS They were included in the treatment group (20 cases) and the control group (20 cases). The treatment group was given bacterial lysate, while the control group was given placebo. The clinical efficacy and incidence of adverse events were observed before and 3,6 and 12 months after treatment in both groups. The levels of salivary IgA (s Ig A) in the corresponding window period were also measured. Results During the observation period, the number of wheezing episodes and symptom scores in treatment group were significantly decreased, sialic saliva s Ig A was significantly higher than the control group, and the percentage of eosinophils in the peripheral blood was significantly negatively correlated. No significant adverse reactions during treatment. Conclusions Bacterial lysates can increase salivary s Ig A level, enhance local respiratory mucosal immunity, and reduce the probability of recurrent respiratory tract infections in children, thus effectively reducing wheezing episodes.